Novel Therapy for Poor Responders Management

Poor Ovarian Response Clinical Trial

Official title:

Novel Therapy for Poor Responders Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310293
• Other study ID #: Kamal-Rageh
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2020
• Source: Al Baraka Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are <41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of the Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU & Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before

Description:

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are <41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU & Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 45 Years

Eligibility

Inclusion Criteria:

• All with AFC =3,

• AMH;=0.5

• and they give only =3 oocytes in their previous cycles

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Poor Ovarian Response

Intervention

Other:
• Femara,Grotwth hormone,HMG
NOVEL THERAPY

Locations

Country	Name	City	State
Bahrain	Al-BARAKA FERTILITY HOSPITAL	Manama

Sponsors (1)

Lead Sponsor	Collaborator
Al Baraka Fertility Hospital

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NUMBER OF OOCYTES	NUMBER	2 weeks